The propose for this study is to evaluate the safety and tolerability of desmopressin when administered perioperatively to patients with breast cancer undergoing surgery as first treatment, and select the optimum dose for the clinical development of the product.
Breast cancer is one of the most commonly diagnosed malignancies among women, and its mortality is related to the capacity of tumor cells to invade and produce metastases. It is postulated that tumor manipulation during surgery results in the release of tumor cells into circulation or the lymphatic system, and that these released cells survive due to aggregation among them or with platelets through the formation of a fibrin layer on the embolus. Tumor cells surviving transportation through circulation will join blood vessels and invade vascular walls, forming metastases. The interruption of this process might reduce survival of tumor cells and thus the formation of metastases from breast cancer cells in the lungs or other tissues.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
21
20 patients in 5 groups 4 each, advancing progressively to each dose level.
Hospital Interzonal General De Agudos EvaPeron
Buenos Aires, Buenos Aires, Argentina
Selection of the higher safe dose level for ensuing clinical trials
One of the three dose levels assessed in this study will be selected for further clinical testing in adults: 0,50 mg, 1,0 mg, 1,25 mg, 1,5 mg or 2,0 mg.
Time frame: Up to 2 years
Evidence of V2 Receptor Expression
Time frame: Baseline
Evidence of CTC (CIRCULATING TUMOR CELLS)
Time frame: Baseline
Evidence of Von Willebrand factor antigen (VWF:Ag)
Time frame: Baseline
Evidence of CTC (circulating tumor cells)
Time frame: 30 minutes pre surgery and 24 hours post the surgery
Evidence of CTC (circulating tumor cells)
Time frame: 2 Weeks
Evidence of CTC (circulating tumor cells)
Time frame: 1 Month
Evidence of CTC (circulating tumor cells)
Time frame: 3 Months
Evidence of CTC (circulating tumor cells)
Time frame: 6 Months
Evidence of CTC (circulating tumor cells)
Time frame: 12 Months
Evidence of Von Willebrand factor antigen (VWF:Ag)
Time frame: 120 minutes post the surgery
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Evidence of VWF activity (ristocetin cofactor, VWF:RCo)
Time frame: baseline
Evidence of VWF activity (ristocetin cofactor, VWF:RCo)
Time frame: 120 minutes post the surgery
Evidence of FVIII coagulant activity (FVIII:C)
Time frame: baseline
Evidence of FVIII coagulant activity (FVIII:C)
Time frame: 120 minutes post the surgery
Evidence of euglobulin lysis time
Time frame: baseline
Evidence of euglobulin lysis time
Time frame: 120 minutes post the surgery